RLS is a poorly understood disorder in which patients experience compelling urges to move the legs usually accompanied by intense, unpleasant sensations in their legs. RLS affects 5-15% of the American and European populations. RLS affects the general population with a mean age at onset of 27.2 years. Onset of RLS is often before age 20 in 38.3% of patients. Women are twice as likely to be affected. The earliest description of an RLS case was by English physician and anatomist Sir Thomas Willis in 1672. RLS lingered in anonymity until 1944, when Swedish neurologist Karl Ekbom first described the salient features. In 1945 he coined the phrase “restless legs”. The addition of the word “syndrome” designates this malady as a condition defined by clinical symptoms rather than by any specific pathological process.
Most patients find they cannot describe the nature of their sensations. It is frequently unrecognized or misdiagnosed and therefore widely undertreated. Dr. Ekbom felt that “this is evidently due to the fact that the sensations do not resemble any known phenomenon that can be used as a comparison.” They are variably described as heebie-jeebies, antsy, Jimmy legs, or as creeping-crawling, pulling, drawing, boring, wormy, etc. The sensations are painful in about 30% of patients. Patients experience intense unpleasant sensations deep in the legs that are accompanied by an irresistible urge to move the affected limbs. The sensations are usually located in the calf area, but may be felt anywhere from the ankles to the thighs. The arms are rarely involved.
There is a wide variation in severity with some patients experiencing only occasional mild symptoms, while others struggle with disabling episodes on a nightly basis. Symptoms of RLS are worse in the evening and during periods of relaxation or decreased activity, especially while lying down or reclining. Patients are often completely asymptomatic in the morning. The reason for this is unknown. The desire to relieve the symptoms can lead to a compulsion involving excessive limb movements. The sensations and the compulsion to relieve them frequently become terribly distressing. As RLS symptoms are stronger at bedtime, sleep-onset insomnia is common. RLS sufferers often find they cannot sleep until the early morning hours. Patients with severe RLS experience nightly attacks that lead to chronic sleep-deprivation with its accompanying psychological and cognitive deficits.
Investigators have made great strides in the understanding and treatment of RLS over the last two decades, to the nightly relief of millions of victims. The etiology of RLS remains elusive, however, and a final common pathway has yet to be described. According to Dr M. J. Thorpy, primary RLS “may represent a heterogeneous group of disorders because no single pathophysiologic mechanism explains all the clinical features exhibited.”
There are no classic physical findings, no conclusive blood assays, and no standard radiological or sleep studies to diagnose RLS. Because there is no known biomarker, the diagnosis of RLS can only be made based on clinical history. In an attempt to more clearly define RLS, the IRLSSG developed RLS diagnostic criteria in 1995. An IRLSSG consensus panel at the National Institutes of Health (NIH) modified these criteria to their present form in 2003. These four criteria are necessary and sufficient for the diagnosis of RLS. They include: 1) Urges to move the limbs with or without unpleasant sensations, 2) worsening of symptoms at rest, 3) improvement of symptoms with movement, and 4) worsening of symptoms at night. The IRLS questionnaire (FIG. 1) was developed by the IRLSSG and validated in 2003 as a consistent, reliable tool to objectively measure RLS severity.
RLS is divided into primary (idiopathic) and secondary causes. Primary RLS is felt to be the most common form and is suspected to be a sensorimotor abnormality associated with central nervous system dysfunction involving abnormal brain iron metabolism and irregularity of central dopaminergic neurotransmitter pathways. Primary RLS likely represents a heterogenous group because no single pathophysiologic mechanism explains all the clinical features exhibited. Secondary RLS occurs in such disparate conditions as back pain, iron deficiency, renal failure, pregnancy, neuropathy, and venous disease. Various medications are known to precipitate RLS attacks. The fact that RLS is a “mixed bag” diagnosis has complicated research, confounded investigators, and frustrated clinicians; in that various medications work in only a percentage of affected patients. Current treatment therefore focuses on nightly management of symptoms rather than on cure.
In 1995, Dr. A. H. Kanter's groundbreaking study suggested that sclerotherapy in patients with varicose veins and RLS is 98% effective in initial relief of RLS. This is the first article to describe operative treatment of RLS. Dr Kanter concluded that all RLS patients with varicose veins should be considered for phlebological evaluation and possible treatment before being consigned to chronic drug therapy.
Secondary RLS is known to occur in and is secondary to such disparate conditions as iron deficiency, renal failure, pregnancy, neuropathy, and venous insufficiency. Various medications are known to exacerbate existing RLS, even precipitate RLS, and other causes are likely.
Because RLS is a “mixed bag” diagnosis, research investigators have been confounded when treatments only work on a portion of the test subjects. Treatment of the secondary causes of RLS can frequently cure patients of this distressing malady. Because venous insufficiency is a secondary cause, treatment of this cause may cure the patient of RLS.
Venous insufficiency is quite common, affecting 10-15% of adult men and 20-25% of adult women. Duplex ultrasound studies reveal that saphenous vein reflux is the most common form of venous insufficiency and is the underlying condition in most patients suffering with varicose veins. Sclerotherapy in patients with varicose veins and RLS has been shown to be 98% effective in initial relief of RLS with recurrence rate of 8% and 28% at one and two years, respectively. Sclerotherapy is not a very effective treatment for varicose veins. While effective for tiny surface veins, the injection of liquid sclerosant into the large veins responsible for venous insufficiency has a low success rate. This method requires multiple injections, can be very painful, and the veins often reopen in a few years requiring, continual treatments. Most RLS patients are not willing to undergo this therapy. Although prior art consists of drug therapy and occasionally the use of compression stockings, surgery in the form of vein stripping has also not been considered a treatment for this condition because of the significant morbidity associated with the procedure. This invention discloses the use of a new minimally invasive treatment for venous insufficiency that is benign enough to be considered as a treatment and a cure for RLS with a significantly improved benefit to cost ratio.
Varicose veins have been treated in a similar manner except that the clinical symptoms of varicose veins are much more evident. Bulging veins, ulcers, pain and leg tiredness are all symptoms of varicose vein disease. This invention also relates to otherwise healthy legs that do not necessarily show these symptoms but rather an early stage of venous disease that causes RLS without bulging and painful varicose veins.
This connection between venous insufficiency and restless leg syndrome has been noted in the literature but the root cause of the disease and the connections to the venous system is not obvious. It was only through anecdotal comments by patients who had restless leg syndrome and were also successfully treated for varicose veins that the connection became clear. The restless leg symptoms disappeared after treatment for varicose Veins. This invention takes this one step farther and claims that restless legs can be successfully treated even without the symptoms of varicose veins by eliminating venous reflux in a segment adjacent to the twitching or skin movement.
US Pub No. US20030176822A1, published Sep. 18, 2003 to Morganlander discloses a method of treating restless leg syndrome, the method comprising the steps of eliminating reflux from an underlying vein by applying pressure to the leg of the patient. However, it does not teach or anticipate a method of treating restless leg syndrome comprising the step of eliminating reflux from an underlying vein by closing the underlying leg vein permanently as described in present invention.
U.S. Pat. No. 6,797,259, issued Sep. 28, 2004 to Rabinowitz et al. also teaches a method and device to “for delivery of muscle relaxants through an inhalation route which are typically used for the treatment musculoskeletal pain or restless leg syndrome.” However, the “applying energy, such as microwave or laser light” described in Rabinowitz et al. is for “the heating of the muscle relaxant compositions” in an inhalation device, not “to the treatment site”. Applicant submits that Rabinowitz does not teach or anticipate a method of treating restless leg syndrome comprising the step of eliminating reflux from an underlying vein by closing the underlying leg vein permanently.